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EC number: 230-603-6
CAS number: 7216-56-0
7.3.2/1: Main test - Individual and mean corrected OD values and tissue
viabilities for the test item, the negative and positive controls
Mean OD/disc (#)
Mean viability %
Difference of viability %
mean of 3 values (triplicate of the same extract)
The difference of viability between the two replicates of the negative
control group was 33.66% instead of ≤20%. Considering the results
obtained, this deviation was considered as without impact on the
conclusion of the study.
An in vitro eye irritation test using
the Reconstructed human Cornea-like Epithelium (RhCE) (EpiOcular™
tissue) model was performed according to Guideline OECD 492 and in
compliance with GLP to predict the acute eye irritation potential of the
The test substance was applied, as supplied,
at the dose of 50 µL to two DPBS pre-treated RhCE (EpiOcular™ tissue
model) during 30 minutes at 37°C, 5% CO2, 95% humidity (standard culture
conditions). The exposure period was followed by extensive rinsing with
DPBS at room temperature, a 12-minute post-exposure immersion period at
room temperature and a 2-hour post-exposure incubation at standard
culture conditions. The tissue viability was measured by performing a
In the preliminary tests, the test substance
was found not to have direct MTT reducing properties or colouring
potential. In the main test, the mean corrected percent tissue viability
of the RhCE replicates treated with the test substance was 85.49%,
versus 37.65% in the positive control (Methyl acetate).
Therefore, in accordance with Regulation EC
No 1272/2008 and CLP Regulation, the test substance was identified as
not requiring classification for eye irritation or serious eye damage.
No hazard statement and no signal word were required.
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